QAC — Screw Sleeve Bone Fixation Device Class II
Classification Details
- Product Code
- QAC
- Device Class
- Class II
- Regulation Number
- 888.3043
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
A screw sleeve bone fixation device is intended to be implanted in conjunction with a non-resorbable, metallic bone screw where the screw has lost purchase due to loosening, backout, or breakage. The device fits between the screw threads and surrounding bone, and provides increased surface area to create an interference fit to restore stability of the implant construct.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN180065 | woven orthopedic technologies | OGmend Implant System | May 1, 2020 |